Biomedical Engineer - Diagnostic Ultrasound Position Description Position Title: Medical Device Reviewer/Biomedical Engineer - Diagnostic Ultrasound Subject Matter Expert (SME)
Employment Type: Full-Time Employee
Schedule: Monday-Friday, excluding holidays
Location: 100% Telework
Medical Device Reviewer/Biomedical Engineer- Diagnostic UltrasoundFull-Time Remote ContractorThe U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Radiological Health, Division of Radiological Imaging and Radiation Therapy Devices (DHT8C) is seeking a highly qualified professional to provide technical and regulatory expertise in the review of diagnostic ultrasound and medical imaging device submissions. This full-time, fully remote contractor position supports the FDA's mission to ensure the safety, effectiveness, and quality of medical devices throughout their product lifecycle.
Key Responsibilities- Conduct comprehensive technical and scientific reviews of medical device submissions, including 510(k), PMA, Pre-IDE, IDE, De Novo, and 513(g) submissions.
- Evaluate diagnostic ultrasound systems, associated software, and related technologies for safety, effectiveness, performance, and clinical utility.
- Provide subject matter expertise in ultrasound physics, acoustic output, imaging performance, and clinical applications of diagnostic ultrasound.
- Assess device design, engineering documentation, acoustic performance, software functionality, testing methodologies, validation activities, and risk management documentation.
- Review technical reports, engineering analyses, verification and validation data, computational modeling studies, and other supporting scientific documentation.
- Support postmarket surveillance and compliance activities, including evaluation of Medical Device Reports (MDRs), recalls, Establishment Inspection Reports (EIRs), Electronic Product Radiation Control (EPRC) issues, and trade complaints.
- Investigate device performance concerns, adverse events, technical deficiencies, and reported product failures involving marketed devices.
- Provide scientific and technical recommendations regarding device safety, risk assessment, benefit-risk determinations, and regulatory decision-making.
- Prepare written technical reviews, scientific assessments, memoranda, presentations, correspondence, and regulatory recommendations.
- Interpret and apply applicable FDA regulations, guidance documents, consensus standards, and quality system principles to support regulatory evaluations and policy implementation.
- Collaborate with multidisciplinary teams of engineers, scientists, clinicians, and regulatory professionals to address complex medical device issues.
Required Qualifications- Bachelor's degree (B.S.) in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Physics, Acoustics, Medical Physics, or a closely related technical discipline.
- Minimum of five (5) years of professional experience in biomedical engineering, ultrasound technology, acoustics, ultrasonics, medical devices, or a related field.
- Demonstrated research, development, or technical evaluation experience involving medical imaging devices and associated software.
- Experience supporting the research, development, testing, validation, or evaluation of diagnostic ultrasound hardware and/or software systems.
- Experience with artificial intelligence (AI) and machine learning technologies utilized in medical imaging applications, particularly within ultrasound or radiological imaging environments.
- Strong technical writing and communication skills, with the ability to prepare clear and well-supported scientific assessments and regulatory reviews.
Preferred Qualifications- Advanced degree (M.S., Ph.D., or equivalent) in Biomedical Engineering, Physics, Acoustics, Medical Physics, Computer Engineering, or a related field.
- Advanced training, research, or specialized expertise in acoustics, ultrasound physics, biomedical instrumentation, therapeutic ultrasound, or imaging science.
- Experience evaluating innovative, emerging, or novel medical device technologies.
- Experience developing clinical evaluation strategies, performance testing plans, or clinical study protocols for medical devices.
- Knowledge of medical device risk management principles and methodologies.
- Experience supporting FDA-regulated medical devices in areas such as premarket review, quality systems, regulatory affairs, compliance, or postmarket surveillance.
- Familiarity with FDA-recognized consensus standards, guidance documents, and regulatory frameworks related to:
- Diagnostic ultrasound systems
- Medical imaging devices
- Software as a Medical Device (SaMD)
- Artificial intelligence and machine learning-enabled devices
- Radiation-emitting products
- Cybersecurity for medical devices
Must be a US Citizen or full Green Card holder.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
